MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

Model Number 1012632-29

Device Problems Device Damaged by Another Device (2915); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the right common iliac artery.The 9.0 x 29 mm omnilink elite vascular stent delivery system was implanted without issue.An issue occurred during use of another device, requiring use of a snare device, which inadvertently pulled the omnilink stent out of position.The omnilink stent was then snared and removed from the anatomy.No additional intervention was performed to treat the target lesion.The plan is to bring the patient back on a later date for treatment of the target lesion.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents.The investigation determined the cause for the reported difficulties and subsequent treatment were due to the circumstances of the procedure.In this case, the reported ¿during use of the snare device, the snare device pulled the omnilink stent out of position¿ indicates the reported events are related to the circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial mdr, additional information was provided.The snare device got caught on the stent and pulled the omnilink elite vascular stent out of position.The decision was then made to remove the stent, which was removed completely with no complications.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16000413
• MDR Text Key: 305679756
• Report Number: 2024168-2022-12774
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178542
• UDI-Public: 08717648178542
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 1012632-29
• Device Catalogue Number: 1012632-29
• Device Lot Number: 0081241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 159 KG